Randomized Trial of Vaccines for Zaire Ebola Virus Disease.

PREVAC Study Team; Mark Kieh; Laura Richert; Abdoul H Beavogui; Birgit Grund; Bailah Leigh; Eric D'Ortenzio; Seydou Doumbia; Edouard Lhomme; Samba Sow; +27 more... Renaud Vatrinet; Céline Roy; Stephen B Kennedy; Sylvain Faye; Shelley Lees ORCID logo; Niouma P Millimouno; Alseny M Camara; Mohamed Samai; Gibrilla F Deen; Moussa Doumbia; Hélène Espérou; Jerome Pierson; Deborah Watson-Jones ORCID logo; Alpha Diallo; Deborah Wentworth; Chelsea McLean; Jakub Simon; Aurélie Wiedemann ORCID logo; Bonnie Dighero-Kemp; Lisa Hensley; H Clifford Lane ORCID logo; Yves Levy; Peter Piot; Brian Greenwood ORCID logo; Geneviève Chêne; James Neaton; Yazdan Yazdanpanah; (2022) Randomized Trial of Vaccines for Zaire Ebola Virus Disease. The New England journal of medicine, 387 (26). pp. 2411-2424. ISSN 0028-4793 DOI: 10.1056/NEJMoa2200072
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BACKGROUND: Questions remain concerning the rapidity of immune responses and the durability and safety of vaccines used to prevent Zaire Ebola virus disease. METHODS: We conducted two randomized, placebo-controlled trials - one involving adults and one involving children - to evaluate the safety and immune responses of three vaccine regimens against Zaire Ebola virus disease: Ad26.ZEBOV followed by MVA-BN-Filo 56 days later (the Ad26-MVA group), rVSVΔG-ZEBOV-GP followed by placebo 56 days later (the rVSV group), and rVSVΔG-ZEBOV-GP followed by rVSVΔG-ZEBOV-GP 56 days later (the rVSV-booster group). The primary end point was antibody response at 12 months, defined as having both a 12-month antibody concentration of at least 200 enzyme-linked immunosorbent assay units (EU) per milliliter and an increase from baseline in the antibody concentration by at least a factor of 4. RESULTS: A total of 1400 adults and 1401 children underwent randomization. Among both adults and children, the incidence of injection-site reactions and symptoms (e.g., feverishness and headache) was higher in the week after receipt of the primary and second or booster vaccinations than after receipt of placebo but not at later time points. These events were largely low-grade. At month 12, a total of 41% of adults (titer, 401 EU per milliliter) and 78% of children (titer, 828 EU per milliliter) had a response in the Ad26-MVA group; 76% (titer, 992 EU per milliliter) and 87% (titer, 1415 EU per milliliter), respectively, had a response in the rVSV group; 81% (titer, 1037 EU per milliliter) and 93% (titer, 1745 EU per milliliter), respectively, had a response in the rVSV-booster group; and 3% (titer, 93 EU per milliliter) and 4% (titer, 67 EU per milliliter), respectively, had a response in the placebo group (P<0.001 for all comparisons of vaccine with placebo). In both adults and children, antibody responses with vaccine differed from those with placebo beginning on day 14. CONCLUSIONS: No safety concerns were identified in this trial. With all three vaccine regimens, immune responses were seen from day 14 through month 12. (Funded by the National Institutes of Health and others; PREVAC ClinicalTrials.gov number, NCT02876328; EudraCT numbers, 2017-001798-18 and 2017-001798-18/3rd; and Pan African Clinical Trials Registry number, PACTR201712002760250.).

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